Emergency cardiac and electrocardiogram electrode placement system with artificial intelligence

ABSTRACT

An emergency cardiac and electrocardiogram (ECG) electrode placement device with artificial intelligence is disclosed herein. The emergency cardiac and electrocardiogram (ECG) electrode placement device incorporates electrical conducting materials and elastic material into a pad that is applied to a chest wall of a patient, which places multiple electrodes in the appropriate anatomic locations on the patient to quickly obtain an ECG in a pre-hospital setting. The AI program continuously runs EKGs to continuously monitor a patient.

CROSS REFERENCES TO RELATED APPLICATIONS

The Present Application is a continuation-in-part application of U.S.Pat. Application No. 15/990651, filed on May 27, 2018, which is acontinuation application of U.S. Pat. Application No. 15/853578, filedon Dec. 22, 2017, now U.S. Pat. No. 9986929, issued on Jun. 5, 2018,which claims priority to U.S. Provisional Pat. Application No.62/465752, filed on Mar. 1, 2017, now expired, and also claims priorityto 62/530144, filed on Jul. 8, 2017, now expired, each of which ishereby incorporated by reference in its entirety. The presentapplication also claims priority U.S. Provisional Pat. Application No.62/679856, filed on Jun. 3, 2018, U.S. Provisional Pat. Application No.62/679874, filed on Jun. 3, 2018, U.S. Provisional Pat. Application No.62/679022, filed on Jun. 1, 2018, U.S. Provisional Pat. Application No.62/679876, filed on Jun. 3, 2018, and U.S. Provisional Pat. ApplicationNo. 62/680552, filed on Jun. 4, 2018, each of which is herebyincorporated by reference in its entirety.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

BACKGROUND OF THE INVENTION Field of the Invention

The present invention generally relates to ECG devices.

Description of the Related Art

The electrocardiogram (ECG) is an essential test that provides medicalprofessionals with essential information in the management of patientswith a variety of conditions. It is not only of significant importancein the evaluation and management of patients with chest pain, but alsoin patients with shortness of breath, syncope, dizziness, seizures,altered mental status, stroke, psychiatric conditions, overdose,palpitations and many other conditions. It is a bulky system with amultitude of wires and connections.

The ECG provides critical data to the health care provider in managingpatients with multiple medical issues. The time to obtain this data iscritical and often delayed by the current technology. Minutes can becomecritical in the patient with an acute myocardial infarction (heartattack).

Historically, there is training in the interpretation of ECG data, aswell as placement of electrodes on the chest of each patient inanatomically specific positions.

Current ECG placement is done by technicians and providers of varyingmedical background, including paramedics, health care technicians,nursing assistants, nurses, and doctors. The current technology isbulky, with many wires and cables. The placement of the electrodes inthe acquisition of an ECG is specific and requires special training. ECGacquisition is often limited and/or delayed by multiple factors such asbody sweat, ability to transport the ECG device into confined areas,performance of concomitant medical procedures such as cardiopulmonaryresuscitation (CPR). Because of many limitations, medical providers mustmake rapid decisions and potentially delay medical care while ECGtesting is done. As emergency medicine providers, the inventors haveidentified a need for more rapid placement of the ECG electrodes, a moreportable and manageable system that will not compromise medical care,and the need to eliminate electrode placement errors.

Sujdak, U.S. Pat. No. 6847836 for an Emergency ECG Electrode Chest Paddiscloses a chest adapted for use in an emergency room.

Dominguez, U.S. Pat. No. 6560473 for a Disposable ECG Chest ElectrodeTemplate With Built-In Defibrillation Electrodes discloses a templatethat carries ten electrodes.

Most of the prior art involves developing non-conforming devices thathave to be sized independently and are impractical in the confinedquarters of an ambulance. Most of the prior art does not address theability to withstand the application to a chest wall that is diaphoreticor rapidly moving. The devices are bulky and often have a largefootprint thereby obviating the application of other support devices orobscuring radiologic studies. There is very little attention to theability to reduce the frequency of lead detachment. Nor is there muchattention to conforming to multiple ECG recording devices whichtypically occurs during periods of transfer of care from pre-hospital toemergency department to inpatient units. The need to obtain serialmeasurements with a high degree of reproducibility is also missed by theprior art as subtle physiologic changes can suggest significantpathology warranting immediate intervention.

Current management of patients with chest pain presenting to anemergency room is outdated. Patients that present to the emergencydepartment for chest pain that are having a heart attack (acutemyocardial infarction) are initially evaluated with an electrocardiogramor EKG also called an ECG. This EKG is then interpreted by a trainedphysician. Unfortunately, up to 50% of the initial EKGs can be normaldespite presenting with a pending heart attack. This lack of sensitivityfor the initial EKG is why it is so important to obtain multiple serialEKGs to note the subtle electrical changes that help us diagnose a heartattack. Delays in EKG acquisition, interpretation and systematic errorsin EKG electrode placement all compound the problem. Initial assessmentbegins with a triage nurse evaluation with vital signs and an EKG isperformed. Typically the EKG is rushed to a physician to interpret theEKG alone in absence of seeing the patient and this happens well over 20times a shift. If that EKG is reassuring and there are no available bedsin the ER, the patient is often kept in the waiting room while awaitingfurther evaluation by a provider (physician, physician assistant ornurse practitioner). Patients left in the waiting room with complaintsof chest pain are a specific high risk population. Current trends inemergency department care highlight overcrowding and extending waittimes. Most emergency departments are affected by high demand, andincreasing volume especially in the current healthcare climate. Thewaiting room is a dangerous place to be.

BRIEF SUMMARY OF THE INVENTION

The present invention is a system with an emergency cardiac andelectrocardiogram (ECG) electrode placement device (“EXG device”) andmachine running an AI program that incorporates electrical conductingmaterials and elastic material into a pad that is applied to the chestwall placing the electrodes in the appropriate anatomic locations on apatient. The EXG device solves the problem of lead detachment, leadreversal, inability to apply leads due to extremes in physiology, andlack of reproducibility to measure subtle changes. The ease of use withEXG device allows for acquisition of ECGs that would not have beenobtained and therefore limits the opportunity loss of delays indiagnosis and treatment.

Creation of this device will reduce the time to complete anelectrocardiogram (ECG) in the pre-hospital and emergency setting,eliminate systematic error in placement and interpretation of an ECGelectrode, maintain and place electrodes in the proper anatomiclocations across all body types, will not delay management in criticalcase, maintain proper skin contact through different physiologicresponses such as sweat, cold and heat, as well as through medicaltreatment such as CPR, be easy to train providers in application andplacement of ECG electrodes, and be adaptable to scenarios where spaceand situations limit ECG placement.

One aspect of the present invention is an emergency cardiac andelectrocardiogram (ECG) electrode placement device with AI. The devicecomprises a body, electrodes, cables and an electrode connector. Thebody preferably comprises a first extension member, a second extensionmember, a third extension member, a fourth extension member and a fifthextensions member. The body preferably comprises a base layer composedof a flexible material, an adhesive layer composed of a flexiblematerial, and a backing layer attached to an adhesive surface of theadhesive layer. Each of the electrodes comprises a connection stud, acontact pad interface and a contact pad. The electrode connector ispositioned on the body. Each of the second extension member, the thirdextension member, the fourth extension member and the fifth extensionmember extends outward from the first extension member. Each cable ofthe plurality of cables is positioned between the base layer and theadhesive layer, and connected to a corresponding electrode of theplurality of electrodes and connected to the electrode connector. Thefirst extension member comprises a first electrode, a second electrode,a third electrode, a fourth electrode, a fifth electrode and a sixthelectrode of the plurality of electrodes. A seventh electrode of theplurality of electrodes is positioned at a far end of the secondextension member. An eight electrode of the plurality of electrodes ispositioned at a far end of the third extension member. A ninth electrodeof the plurality of electrodes is positioned at a far end of the fourthextension member. A tenth electrode of the plurality of electrodes ispositioned at a far end of the fifth extension member. An AI programcontinuously runs EKGs to continuously monitor a patient.

Another aspect of the present invention is an ergonomic cardiac andelectrocardiogram (ECG) electrode system. The system comprises a device,and an EKG machine running an AI program. The device comprises a bodycomposed of a plurality of extension members, wherein the body comprisesa main layer having a top surface an adhesive surface, and a backinglayer attached to an adhesive surface of the adhesive layer, anelectrical conducting elastic material is incorporated into the topsurface, a plurality of electrodes, each of the plurality of electrodespositioned on the adhesive surface of the main layer, and an electrodeconnector cable extending from the body. The AI program continuouslyruns EKGs to continuously monitor a patient.

Another aspect of the present invention is an emergency cardiac andelectrocardiogram electrode placement device comprising a cablemanagement module, a body, a plurality of electrodes and a plurality ofcables. The cable management module comprises an upper cover, an upperguide piece, a lower guide piece and a lower cover wherein each of theupper guide piece and the lower guide piece has a plurality of channeltherein. The body is composed of a first extension member, a secondextension member, a third extension member, a fourth extension memberand a fifth extensions member. The body comprises a base layer composedof a flexible material, an adhesive layer composed of a flexiblematerial, and a backing layer attached to an adhesive surface of theadhesive layer. Each of the plurality of electrodes comprises aconnection stud, a contact pad interface and a contact pad. Each of thesecond extension member, the third extension member, the fourthextension member and the fifth extension member extends outward from thecable management module. Each cable of the plurality of cables ispositioned between the base layer and the adhesive layer, routed througha channel of the plurality of channels, and connected to a correspondingelectrode of the plurality of electrodes and the electrode connector.

Yet another aspect of the present invention is a method for monitoring apatient having a cardiac event. The method comprises sending a signalfrom an ECG device on a patient via a transmitter to a machineconfigured to run an AI program. The method also comprises interpretingthe signal at the machine suing the AI program to monitor cardiacconditions for the patient. The method also comprises comparing thecardiac conditions to previous cardiac conditions to determine adifference. The method also comprises generating a warning if a cardiacevent is detected by the AI program.

Yet another aspect of the present invention is a prehospital artificialintelligence continuous EKG reading and interpretation placement system.The system comprises an emergency cardiac and electrocardiogram (ECG)electrode device with a first wireless transmitter, and a PACER systemor a mobile communication device with a PACER mobile application. TheECG device with incorporated wireless transmitter and linking to thePACER system enables identification of evolving myocardial infarctionand subtle changes consistent with acute coronary syndrome. The PACERsystem or the PACER mobile application evaluates rapid reassessments ofEKG wave morphology and rhythm changes to predict and diagnose acutecoronary or significant cardiac arrhythmias using tangible softwareconfigured with instructions to determine specific changes such as STsegment elevations of more than 1 mm in contiguous leads in comparisonto prior EKGs or set norms and alert multiple providers of thesechanges, and also records these findings and transmit them to providers,and answers the question if there is a change in diagnosis andprognostication to warrant emergent treatment.

Having briefly described the present invention, the above and furtherobjects, features and advantages thereof will be recognized by thoseskilled in the pertinent art from the following detailed description ofthe invention when taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 is an illustration of an emergency cardiac and ECG electrodeplacement system used by a technician on a patient.

FIG. 2 is a top plan view of a first embodiment of an emergency cardiacand ECG electrode placement device in a storage state.

FIG. 3 is top plan view of a first embodiment of an emergency cardiacand ECG electrode placement device in an application state.

FIG. 4 is a side elevation view of a first embodiment of an emergencycardiac and ECG electrode placement device in a storage state.

FIG. 5 is a top plan view of a second embodiment of an emergency cardiacand ECG electrode placement device in an application state.

FIG. 6 is an isolated top plan view of a second embodiment of anemergency cardiac and ECG electrode placement device in an applicationstate.

FIG. 7 is a top perspective view of a second embodiment of an emergencycardiac and ECG electrode placement device in an application state.

FIG. 8 is an isolated exploded view of a control module of a secondembodiment of an emergency cardiac and ECG electrode placement device.

FIG. 9 is an isolated top perspective view of an electrode of anemergency cardiac and ECG electrode placement device.

FIG. 10 is an isolated exploded view of an electrode of an emergencycardiac and ECG electrode placement device.

FIG. 11 is an isolated cross-sectional view of an extension of is anisolated view of an electrode of an emergency cardiac and ECG electrodeplacement device.

FIG. 12 is a top perspective view of a connection module for anemergency cardiac and ECG electrode placement device.

FIG. 13 is an exploded top perspective view of a connection module foran emergency cardiac and ECG electrode placement device.

FIG. 14 is an isolated view of a side extension for an emergency cardiacand ECG electrode placement device.

FIG. 15A is an isolated view of a wireless emitter for an emergencycardiac and ECG electrode placement system.

FIG. 15B is an isolated view of a wireless receiver for an emergencycardiac and ECG electrode placement system.

FIG. 16 is a bottom plan view of a second embodiment of an emergency.

FIG. 17 is an isolated top plan view of a second embodiment of anemergency cardiac and ECG electrode placement device in an applicationstate with an un-extended extension.

FIG. 17A is an isolated top plan view of a second embodiment of anemergency cardiac and ECG electrode placement device in an applicationstate with an extended extension.

FIG. 18 is an illustration of a human body showing a chest skeleton andmarkers for electrode placement.

FIG. 19 is an illustration of a human body showing a chest skeleton andmarkers for electrode placement with an overlay of the emergency cardiacand ECG electrode placement device.

FIG. 20 is an illustration of a first embodiment of an emergency cardiacand ECG electrode placement device positioned on a patient.

FIG. 21 is an illustration of a second embodiment of an emergencycardiac and ECG electrode placement device positioned on a patient.

FIG. 22 is an illustration of a third embodiment of an emergency cardiacand ECG electrode placement device with a defibrillation mechanismpositioned on a patient.

FIG. 22A is an illustration of a fourth embodiment of an emergencycardiac and ECG electrode placement device with a defibrillationmechanism positioned on a patient.

FIG. 22B is an illustration of a fifth embodiment of an emergencycardiac and ECG electrode placement device with a defibrillationmechanism positioned on a patient.

FIG. 22C is an illustration of a sixth embodiment of an emergencycardiac and ECG electrode placement device with a defibrillationmechanism positioned on a patient.

FIG. 23 is an illustration of a seventh embodiment of an emergencycardiac and ECG electrode placement device positioned on a patient.

FIG. 23A is an illustration of an eighth embodiment of an emergencycardiac and ECG electrode placement device positioned on a patient vice.

FIG. 23B is an illustration of a ninth embodiment of an emergencycardiac and ECG electrode placement device positioned on a patient.

FIG. 23C is an illustration of a tenth embodiment of an emergencycardiac and ECG electrode placement device positioned on a patient.

FIG. 24 is an illustration of an eleventh embodiment of an emergencycardiac and ECG electrode placement device positioned on a patient.

FIG. 24A is an illustration of a twelfth embodiment of an emergencycardiac and ECG electrode placement device positioned on a patient.

FIG. 25 is an isolated top perspective view of a top surface of anextension of an emergency cardiac and ECG electrode placement device.

FIG. 26 is an isolated bottom plan view of a bottom surface of anextension of an emergency cardiac and ECG electrode placement device.

FIG. 27 is an isolated top plan view of a top surface of an extension ofan emergency cardiac and ECG electrode placement device.

FIG. 28 is an isolated top perspective view of a top surface of anextension of an emergency cardiac and ECG electrode placement device.

FIG. 28A is an isolated exploded cross-sectional view of the extensionof an emergency cardiac and ECG electrode placement device of FIG. 28and an electrode.

FIG. 28B is an isolated bottom view of an electrode for an emergencycardiac and ECG electrode placement device.

FIG. 28C is an isolated top view of an electrode for an emergencycardiac and ECG electrode placement device.

FIG. 29 is an isolated view of a portion of an emergency cardiac and ECGelectrode placement device.

FIG. 30 is an isolated cross-sectional view of an bi-layer extension ofwith an electrode of a device.

FIG. 30A is an exploded view of FIG. 30 .

FIG. 31 is an isolated cross-sectional view of a single layer extensionof with an electrode of a device.

FIG. 31A is an exploded view of FIG. 31 .

FIG. 32 is an image for an ergonomic cardiac and ECG electrode system.

FIG. 33 is an image for an ergonomic cardiac and ECG electrode system.

FIG. 34 is an image for an ergonomic cardiac and ECG electrode system.

FIG. 35 is an image for an ergonomic cardiac and ECG electrode system.

FIG. 36 is an image for an ergonomic cardiac and ECG electrode system.

FIG. 37 is an image for an ergonomic cardiac and ECG electrode system.

FIG. 38 is an image for an ergonomic cardiac and ECG electrode system.

FIG. 39 is an image for an ergonomic cardiac and ECG electrode system.

FIG. 40 is an image for an ergonomic cardiac and ECG electrode system.

FIG. 41 is an image for an ergonomic cardiac and ECG electrode system.

FIG. 42 is an image for an ergonomic cardiac and ECG electrode system.

DETAILED DESCRIPTION OF THE INVENTION

With current technology utilizing the EXG-system and artificialintelligence (AI) algorithms, the potential to expand the emergencydepartment safely to include the waiting room is now feasible. Thepotential to monitor all patients with chest pain remotely and safelywith diagnostic AI systems will decrease missed diagnosis, increaseaccuracy, and improve safety throughout the healthcare system. The EXGsystem coupled with a continuous 12 lead central monitoring system usingpatented artificial intelligence to detect subtle changes in the EKGregardless of patient location is now a reality. With application of aportable reliable and diagnostic EKG monitoring device, the EXG willinterface wirelessly with a central processing unit capable of detectingsubtle EKG changes dynamically and alert providers of these changes. Itis a perfect blend of AI and healthcare aimed at saving lives.Preferably, if a cardiac event is detected, an alarm is sent to thedevice to signal which patient is having the cardiac event. This isimportant if the patient is in a waiting room at a hospital.

Current systems evaluate patients with acute coronary syndrome withpoint estimate EKG and serial serum enzyme testing. Recurrent episodesof chest pain and heart attack are often missed due to delays in EKGacquisition and identification for subtle changes in the EKG. Thesepoint estimates have been the only feasible option for healthcareproviders, until now. Patients at high risk for disease especially inthe era of emergency department overcrowding and delays and triage andpatient assessment raise the risk for morbidity and mortaility. Serialassessments of ST segment and other subtle changes indicative of acutecoronary syndrome are time consuming, resource consuming and notfeasible with the current systems. The EXG-system, with its reliableplacement, reproducible data acquisition, ease of use, mitigated motionartifact, allows diagnostic AI to monitor for subtle changes indicativeof cardiac pathology continuously. The EXG-system coupled withcontinuous 12 lead EKG monitoring and wireless connectivity and AIprocessing will better identify patients with acute coronary syndrome,minimize risk of missed MI, and contribute to better patient outcomes.

The ability of AI to perform near continuous evaluation of multiple EKGson multiple patients simultaneously is something that would be anunconventional and non-routine practice scope of any clinician. Onepatient could receive continuous EKGs on the order of up to 20 or moreEKGs per minute. The AI engine would be able to continuously monitormultiple patients at a time with multiple EKGs done during themonitoring period, and that would not be feasible for any clinician.Imagine 20 patients undergoing 20 EKGs per minute over the course of a20-48 hour hospital stay. Thousands of data points being continuouslymonitored and evaluated with diagnostic precision. This novel systemapproach to evaluating patients with presentations concerning for acutecoronary syndrome will potentially decrease frequency of actual EKGacquisition as the AI will identify when changes occur, thus promptingrepeat EKG evaluation versus predetermined arbitrary point estimate EKGacquisition. Potentially obviating need for repeat EKGs if no changesare noted. This will lead to saving lives, saving time and giveclinicians increased confidence in evaluating these patients regardlessof patient location.

The AI engine will receive data from a continuous signal via wireless orwired technology via the EXG device or any 12 lead continuous monitoringdevice attached to patient(s) to get a first EKG, second EKG andsubsequent serial EKGs over set intervals that will do standard EKGinterpretation but also compare second EKG and subsequent serial EKGs tothe first EKG and/or baseline EKG and interpret changes. The AI enginewill then be able to determine any significant changes concerning foracute coronary syndrome, arrhythmia, or other diagnostic criteria fordynamic EKG changes in the setting of acute coronary syndrome. Oncechanges or significant findings are made, algorithms will be in place toalert providers of these findings in real time. Data will be stored.Stored data will be available for review and integration into patientcharts and records.

In summary, the EXG device will now allow diagnostic continuous 12 leadEKG monitoring easily, quickly, reliably and safely. Incorporation ofthe device with an AI system will decrease the risk of missed MI in thewaiting room, on the patient floor, and in the emergency department.Similar benefits of an EXG-AI combination could be seen for patients whopresent with syncope (Sudden loss of consciousness) where the event maybe related to intermittent arrhythmias that cause an unstable functionof the heart and require pacemaker insertion. This EXG-AI combinationessentially turns every space into a cardiac monitored space thusimproving the resources for an entire hospital where patients now maywait specifically to placed on a ward with cardiac monitors as themajority of non-ICU hospital rooms do not have cardiac monitorsinstalled.

As shown in FIG. 1 , the emergency cardiac and electrocardiogram (ECG)electrode placement device (“EXG device”) 20 is a worn device thatincorporates electrical conducting materials and elastic material into apad that is applied to the chest wall placing the electrodes in theappropriate anatomic locations on a patient 15. A technician 10, such asan emergency responder, places the EXG device 20 on the patient 15 andconnects the EXG device 20 to an ECG machine 16 which generates an ECG17.

As shown in FIG. 3 , the EXG device 20 preferably comprises a body 21,electrodes 50, cables 60 (not shown), and an electrode connector 71. Thebody 21 preferably comprises a first extension member 22, a secondextension member 23, a third extension member 24, a fourth extensionmember 25 and a fifth extension member 26. The electrode connector 71 ispositioned on the body 21. Each extension member 22-26 preferably has awidth ranging from 1 cm to 10 cm, and a length ranging from 5 cm to 20cm.

A second embodiment of EXG device 20 is shown in FIGS. 5-7 . Each of thefirst extension member 22, the second extension member 23, the thirdextension member 24, the fourth extension member 25 and the fifthextension member 26 extends outward from the center of the body 21. Thefirst extension member 22 preferably comprises a first electrode 50 a, asecond electrode 50 b, a third electrode 50 c, a fourth electrode 50 d,a fifth electrode 50 e (not shown) and a sixth electrode 50 f (notshown). A cable 60 a connects the electrode 50 a to the electrodeconnector 71. A cable 60 b connects the electrode 50 b to the electrodeconnector 71. A cable 60 c connects the electrode 50 c to the electrodeconnector 71. A cable 60 d connects the electrode 50 d to the electrodeconnector 71. Although not shown, a cable 60 e connects the electrode 50e to the electrode connector 71, and a cable 60 f connects the electrode50 f to the electrode connector 71.

A seventh electrode 50 g is positioned at a far end 23 a of the secondextension member 23, and a cable 60 g connects the electrode 50 g to theelectrode connector 71. An eight electrode 50 h is positioned at a farend 24 a of the third extension member 24, and a cable 60 h connects theelectrode 50 h to the electrode connector 71. A ninth electrode 50 i ispositioned at a far end 25 a of the fourth extension member 25, and acable 60 i connects the electrode 50 i to the electrode connector 71. Atenth electrode 50 j is positioned at a far end 26 a of the fifthextension member 26, and a cable 60 j connects the electrode 50 j to theelectrode connector 71. The far ends 23 a, 24 a, 25 a, 26 a of theextension members 23, 24, 25, 26 and even the far end of extensionmember 22, act as strip extensions that assist in placing the electrodecorrectly. This strip extension is approximately 1 to 2 inches in lengthas measured from the electrode.

The EXG device 20 of FIG. 5 also comprises a sixth extension member 27with an electrode 50 k and a seventh extension member 28 with anelectrode 501. A cable 60 k connects the electrode 50 k to the electrodeconnector 71, and a cable 60 i connects the electrode 501 to theelectrode connector 71.

The EXG device 20 of FIGS. 5-8 includes a cable management module 100.The cable management module 100 comprises an upper cover 101, an upperguide piece 102, a lower guide piece 103 and a lower cover 104. Each ofthe upper guide piece 102 and the lower guide piece 103 has a pluralityof channels 110 therein for guiding the cables 60 therethrough. Thechannels 110 of the cable management module 100 allow for the extensionof an extension member to fit a patient, without the cables 60 becomingtangled.

As shown in FIG. 11 , each extension member of the body 21 preferablycomprises a base layer 30 composed of a flexible material, an adhesivelayer 31 composed of a flexible material, and a backing layer 32attached to an adhesive surface 31 a of the adhesive layer 31. Onepreferred material for the flexible material is KT TAPE from Spidertech.The base layer 30 preferably has a Shore A hardness ranging from 50 to90, which better allows for chest compressions. One preferred materialfor the adhesive layer is an adhesive from 3 M. As shown in FIGS. 9-10 ,each of the electrodes 50 preferably comprises a connection stud 51, acontact pad interface 52 and a contact pad 53. Each contact pad 53 ispreferably has a diameter ranging from 30 milliimters (“mm”) to 40 mm,and most preferably 35 mm, to in one embedment allow for retention of agel protector. Each contact pad 53 is preferably composed of a materialfrom 3 M. A cable connector 61 of each cable 60 is connected to aconnection stud 51 of each electrode 50 preferably using a conductiveepoxy. Each cable connector 61 is preferably composed of 0.2 mm thickcopper, with a 26 mm inside diameter. Each cable 60 of the plurality ofcables 60 is positioned between the base layer 30 and the adhesive layer31. Each cable 60 is connected to a corresponding electrode 50 of theplurality of electrodes 50 and connected to the electrode connector 71.Each cable 60 is preferably shielded to prevent electrical interference.Each of the plurality of cables preferably as an outer diameter rangingfrom 0.008 inch to 0.310 inch.

As shown in FIGS. 2 and 4 , the EXG device 20 is preferably provided ina compact, easily stored and transported form, that is then applied to apatient’s chest wall with materials that have adhesive capabilities thatpreferably resist moisture and conforms to the patient’s body withinherent elasticity with placement of electrodes within a pad thatmaintain proper anatomic ratios and locations. The EXG device 20preferably remains adherent to the patient’s body through the durationof the acute pre-hospital and transition through the emergencydepartment and acute hospitalization care periods (which is typicallythree days), but the EXG device 20 remains easily removable, whiletolerating physiologic changes such as sweat, fever and medicaltreatment such as cardiac pulmonary resuscitation (“CPR”). The EXGdevice 20 is clearly marked and designed to fit to the chest wall sothat its application ensures proper placement of all electrodes on thepatient. The incorporated electrical conducting materials come togetherinto a single cable/wire that is either directly or indirectly joined toan ECG monitoring device. The cable has adaptor capability that allowsfor wireless transfer of data to an ECG monitoring device obviating theneed for having a bulky ECG machine in close proximity to the patient.The single cable also eliminates the need for multiple wires on apatient. Multiple wires that could potentially interfere with diagnosticimaging such as chest radiographs, or interfere with placement ofemergency medical equipment such as transcutaneous cardiac pacer pads ordefibrillating pad.

The EXG device 20 reduces the time to perform ECG testing significantly.With proper training, a user can anticipate ECG acquisition in less thanone minute, and potentially within seconds. Current ECG data can takeseveral minutes or longer depending on the care setting. It is notunusual for an ECG ordered in a hospital setting to take more than 10-30minutes.

The EXG device 20 also eliminates lead transposition error. That is, theattachment of an electrode wire in a wrong electrode.

The EXG device 20 makes ECG data more reliable and reproducible. Thereis no variation in lead placement while performing serial ECGs --whichis often done in the hospital and pre-hospital setting. The incorporatedelastic electro-conductive materials allow for this small form factor toaccommodate varying body types (man, women, adult, child, obese,anorexic) while maintaining strict anatomic ratios and correct placementand ensure proper lead placement.

The ease of use of the EXG device 20 makes ECG acquisition lessinconvenient and potentially improves ECG utilization in thepre-hospital setting. The EXG device 20 also reduces the frequency oflead detachment. An alternative embedment of the EXG system has wirelesstransfer capability that makes acquisition of the ECG in any situationfeasible. The EXG device 20 preferably incorporates either integratedelastic electro-conductive materials or printable elasticelectro-conductive material used in the acquisition of electricalsignals from the electrodes. The EXG device 20 adheres to skin surfacesthrough a variety of physiologic conditions not currently met by currentmethods.The EXG system allows for acquisition of data in settings thatstandard methods currently fail. Existing technology for ECG acquisitionrelies on technical expertise in lead placement. Removing technicalerror is dependent of operator knowledge and skill, as well asinterpretation of ECG data to identify systemic error in placement. Thetime to acquire an ECG is dependent on many factors but is limited dueto the number of electrodes that are placed on the chest and torso,which then need to be attached to the ECG device. There are preferably aminimum of ten wires involved, and more electrodes are possible to allowfor more specific views of the right side of the heart and/or posteriorheart leads.

The EXG device 20 is preferably a single device with embedded leadplacement through a wearable material (such as a fabric) with a smallphysical footprint with the elasticity to maintain physiologicmeasurement across different ages, gender and body habitus withoutrequiring multiple sized devices.

In one embodiment, the EXG device preferably comprises: adhesivestretchable material that is breathable and water/sweat resistant;embedded elastic electroconductive material conducting electricalsignals from the integrated cardiac electrodes to a central data cable;embedded elastic electroconductive material/wiring/cabling arranged toallow for stretching across body types and sizes; electrode connectionport; Bluetooth capable emitter and receiver; conduction gel; andembedded electrodes (manufactured or printable).

The elastic adhesive membrane preferably provides adherence to bodysurface. It is preferably tolerant to moisture. The EXG devicepreferably incorporates electroconductive materials and electrodes thatconduct signal from the skin to a single data cable/wire. The EXG devicepreferably expands in an elastic fashion to appropriately fit variedbody types while meeting exact ratios of electrode distance withoutdistortion. The EXG device preferably has significant stability of sizeand shape with elastic components to make it easily applicable to thechest wall. The EXG device preferably comes in a compact form factor.

In one embodiment, there is encapsulated expandable electroconductivematerial within the membrane. Within the elastic membrane isincorporated electroconductive materials that originate from eachelectrode to come together into a single data cable encompassing aminimum of ten ECG wires to allow for a standard twelve lead ECG (byconvention there are two leads that are inferred from the tenconnections).

Alternatively, the EXG device allows for the use of external electrodes.In the event that ECG monitoring equipment is not compatible with thedata cable, electrodes at the ascribed anatomical locations can beaccessed with standard medical cardiac monitoring and ECG devices.

In one embodiment, there is a conductive membrane at ECG electrodesites. At the ascribed electrode ECG locations is a typicalelectroconductive Ag/AgCL membrane to conduct current from body surfaceto ECG monitoring device.

In one embodiment, a data cable brings individual electrodes into onecable that encompasses a minimum of ten wires/leads of the typical ECGanalysis which is then compatible with various ECG devices and wirelesstransfer system. Other conductive interfaces may be utilized with theinvention including ones composed of graphene/carbon, nickel, andcopper.

In use, one applies the EXG device 20 to an anterior chest walloverlying the sternum symmetrically at a level above the nipple line ofthe patient and below the sternal notch, removing the backing layer 32to expose the adhesive surface 31 a of the adhesive layer 31. Theprecordial limb is then stretched to the lateral chest wall at the midaxillary line below the nipple line. Similarly each limb will have thebacking layer 32 removed in succession to expose the adhesive surface 31a of the adhesive layer 31. The right upper extremity limb is stretchedtowards the right shoulder. The left upper extremity is stretchedtowards the left shoulder. The right lower extremity limb is stretchedto the right lower abdominal quadrant. The left lower extremity limb isstretched to the left lower abdominal quadrant. The cable is eitherattached to directly to the ECG device cable. Or in versions utilizing aBLUETOOTH transceiver, then the EXG device 20 is activated to sync withthe BLUETOOTH transceiver that is already connected to the ECG device.

A preferred embodiment of a connector module 70 is shown in FIGS. 12-13. The connector module 70 preferably comprises a top cover portion 170,a bottom cover portion 176, a plurality of connector pins 175 and afifteen pins sub connector 177. An interface connector 180 is alsoshown.

A posterior extension member 29 is shown in FIG. 14 . This additionalposterior extension member 29 preferably has multiple electrodes thatconnect via cable 142 to an intermediary adapter module 141 whichconnects to the electrode connector 72. The posterior leads preferablyare connected through the adapter module 141 onto the end of theoriginal EXG device 20 and basically take over leads V5-6 for thestandard ECG.

As shown in FIGS. 15A and 15B, in an alternative embodiment, the EXGdevice 20 comprises a wireless emitter 151 and a wireless receiver 152.The wireless emitter 151 is connected to electrode connector 72, and thewireless receiver is connected to the ECG machine 16. The wirelessemitter 151 and the wireless receiver 152 preferably operation on aBLUETOOTH communication protocol.

As shown in FIG. 16 , the EXG device 20 also preferably comprises aplurality of external electrodes 80. A third extension member 24comprises a first external electrode 80 a. A second extension member 23comprises a second external electrode 80 b. A first extension member 22comprises a third external electrode 80 c. A fifth extension member 26comprises a fourth external electrode 80 d. A fourth extension member 25comprises a fifth external electrode 80 e.

FIGS. 17 and 17A illustrate the stretching capability of the extensionmembers of the EXG device 20. The extension member 23 extends from alength L1 (as shown in FIG. 17 ) to a length L2 (as shown in FIG. 17A).In a preferred embodiment, each extension member 23, 24, 25 and 26extends from a length L1 ranging from 7.0 to 14.0 inches to a length L2ranging from 10.0 to 16.5 inches. In a most preferred embodiment, L1ranges from 10 to 11 inches, and L2 ranges from 12 to 13 inches. A widthof each extension member 22, 23, 24, 25, 26 preferably ranges from 1centimeter (“cm”) to 10 cm, and most preferably 2.5 cm to 5 cm. Athickness of each extension member 22, 23, 24, 25, 26 preferably rangesfrom 0.1 inch to 0.5 inch.

FIG. 18 is an illustration of a human body showing a chest skeleton andmarkers for electrode placement. FIG. 19 is an illustration of a humanbody showing a chest skeleton and markers for electrode placement withan overlay of the emergency cardiac and ECG electrode placement device20.

As shown in FIGS. 20 and 21 , the EXG device 20 preferably comprises abody 21, electrodes 50, printed wires or an electrical conductingflexible material 60 (not shown), and an electrode cable connector 71.The body 21 preferably comprises a center extension member 22, a firstextension member 23, a second extension member 24, a third extensionmember 25 and a fourth extension member 26. The electrode cableconnector 71 is positioned on the body 21. Each extension member 22-26preferably has a width ranging from 1 cm to 10 cm, and a length rangingfrom 5 cm to 20 cm. The center extension member 22 preferably comprisesa first electrode 50 a, a second electrode 50 b, a third electrode 50 c,a fourth electrode 50 d, a fifth electrode 50 e and a sixth electrode 50f. Printed wires or electrical conducting flexible material 60 (notshown) connect each electrode 50 to the electrode cable connector 71.

Other embodiments of EXG device 20 are shown in FIGS. 23, 23A, 23B, 23C,24 and 24A. The extension members extend outward from the center of thebody 21.

As shown in FIG. 29 , a printed wire 60 a connects the electrode 50 a tothe electrode cable connector 71. A printed wire 60 b connects theelectrode 50 b to the electrode cable connector 71. A printed wire 60 cconnects the electrode 50 c to the electrode cable connector 71. Aprinted wire 60 d connects the electrode 50 d to the electrode cableconnector 71. A printed wire 60 e connects the electrode 50 e to theelectrode cable connector 71. A printed wire 60 f connects the electrode50 f to the electrode cable connector 71. A printed wire 60 g connectsthe electrode 50 g to the electrode cable connector 71. A printed wire60 h connects the electrode 50 h to the electrode cable connector 71. Aprinted wire 60 i connects the electrode 50 i to the electrode cableconnector 71. A printed wire 60 j connects the electrode 50 j to theelectrode cable connector 71. A ten pin electrode interface 75 connectsto the electrode cable connector 71. On one embodiment, the elasticelectrically conductive material is preferably applied with a 3D printerdirectly on the main layer.

Alternatively, an elastic conductive material is substituted for each ofthe printed wires in FIG. 29 . Such elastic conductive materialspreferably comprise silver chloride and/or graphene. The body 21 ispreferably composed of a kinesiology type tape.

Alternative embodiments of the EXG device 20 a shown in FIGS. 22, 22A,22B, and 22C also comprise integrated defibrillation pads 40 a and 40 bconnected to a defibrillation cable 41. In the unstable patient,defibrillation becomes a crucial aspect of emergency cardiac care. Theuse of defibrillation pads has in the field historically been done withpad placement at the discretion of the first responder/paramedic. Themost common deployment being anteriorly. This often leads to suboptimalplacement and suboptimal delivery of electricity. The EXG-DF withdefibrillator pad assures proper placement of the device in the anteriorposterior configuration, which allows for optimal electrical conductanceto the heart. The vector of electrical conductance is optimally placedin an anterior posterior configuration. There is no device that providesoptimal defibrillator pad placement while integrating twelve lead EKGability with ability to extend to include posterior and right sided leadEKG. The ability to obtain instant EKG data after criticaldefibrillation has heretofore been impractical for the pre-hospital careprovider. The EXG-DF-DF addresses this critical issue in cardiac care.

FIG. 25 illustrates an isolated top perspective view of a top surface ofan extension of the EXG device 20. The extension has a top layer 30 awith an integrated printed wire (or elastic electrical conductingmaterial) 60 connected to an electrode interface 55 integrated with anelectrode 50 that is positioned on an adhesive surface below. Theelectrode 50 is not positioned on the top surface 30 a of the main layer30.

FIG. 26 illustrates an isolated bottom plan view of a bottom surface ofan extension of an EXG device 20. On bottom adhesive surface 30 b of themain layer 30 has electrodes 50 positioned thereon.

FIG. 27 illustrates an isolated top plan view of a top surface of anextension of the EXG device 20. The main layer 30 of the extension has atop layer 30 a with an integrated printed wires (or elastic electricalconducting material) 60 d, 60 e and 60 f connected to correspondingelectrodes 50 d, 50 e and 50 f that are positioned on an adhesivesurface below. The electrodes 50 d, 50 e and 50 f are not positioned onthe top surface 30 a of the main layer 30.

FIG. 28 is an isolated top perspective view of a top surface of anextension of the EXG device 20. The extension has a top layer 30 a withan integrated printed wire (or elastic electrical conducting material)60 connected to an electrode interface 55 integrated with an electrode50 that is positioned on an adhesive surface below. The electrode 50 isnot positioned on the top surface 30 a of the main layer 30. FIG. 28A isan isolated exploded cross-sectional view of the extension of the EXGdevice 20 of FIG. 28 and an electrode 50. The interface 55 is placedthrough an aperture 35 in the main layer 30 to connect to the integratedprinted wire (or elastic electrical conducting material) 60. FIG. 28B isan isolated bottom view of an electrode 50 for an EXG device 20. FIG.28C is an isolated top view of an electrode 50 with an interface 55 foran EXG device 20. The interface is preferably composed of a conductivematerial such as graphene or silver chloride. The electrode 50 ispreferably composed of a silver chloride material.

A bi-layer extension is shown in FIGS. 30 and 30A. Each extension memberof the body 21 preferably comprises a top layer 30 composed of aflexible material and an adhesive layer 31 composed of a flexiblematerial, with a removable backing layer attached to an adhesive surfaceof the adhesive layer 31. A top surface of the adhesive layer preferablyincludes an integrated printed wire (or elastic electrical conductingmaterial) 60 with a connector 61. One preferred material for theflexible material is KT TAPE from Spidertech. The top layer 30preferably has a Shore A hardness ranging from 50 to 90, which betterallows for chest compressions. One preferred material for the adhesivelayer is an adhesive from 3 M. Each of the electrodes 50 preferablycomprises a connection stud 51 and a contact pad 52. Each contact pad 52is preferably has a diameter ranging from 30 milliimters (“mm”) to 40mm, and most preferably 35 mm, to in one embedment allow for retentionof a gel protector. Each contact pad 52 is preferably composed of amaterial from 3 M. A cable connector 61 is connected to a connectionstud 51 of each electrode 50 preferably using a conductive epoxy. Eachcable connector 61 is preferably composed of 0.2 mm thick copper, with a26 mm inside diameter.

FIGS. 31 and 31A illustrate an isolated cross-sectional view of a singlelayer extension. A top surface of the main layer 30 has an integratedprinted wire (or elastic electrical conducting material) 60 with aconnector 61. Each electrode 50 is attached to an adhesive surface ofthe main layer 30 with a stud extending through an aperture to connectto the connector 61.

FIGS. 32-42 illustrate various images of an ergonomic cardiac and ECGelectrode system with artificial intelligence.

A preferred source for the printed wires is PE874 conductor ink fromIntexar Dupont. A conductive elastic rubber material is disclosed inU.S. Pat. No. 8491884. A stretchable graphene film material is disclosedin Chen et al., U.S. Pat. Publication No. 20150273737. A flexibleconductive material comprising silver is disclosed in Taguchi et al.,U.S. Pat. Publication No. 20130056249.

The emergency cardiac and ECG electrode placement device 20 is capableof being applied to a patient while an emergency vehicle is in motionsince the device 20 is applied to and adheres to a patient’s chest area,which mitigates signal loss. Likewise, the emergency cardiac and ECGelectrode placement device 20 is capable of being applied to a patientthat is moving due to a seizure, aggressiveness, and the like.

The entire hospital becomes a telemetry floor since with AI running, thepatient can be anywhere in the hospital and thus the patient does notneed to be moved to a telemetry floor.

The 12 lead acquisition device allows for monitoring patient in thehospital once the patient is fitted with an EXG device with wirelesscommunication capability.

The AI program constant monitoring of multiple patients wearing the EXGdevice alerts when a patient is having an event such as a heart attack.

Each EXG device preferably has a wireless transceiver for communicatingwith a machine running the AI program, which also has a wirelesstransceiver. The communication protocol is preferably BLUETOOTH, lowenergy BLUETOOTH, WiFi, and the like.

The AI program preferably runs on an EKG machine.

The electronic medical records (“EMR”) data of a patient includesgeneral health records, medical procedure records, allergies, illnesses,and the like of the patient.

The networks utilized with the present invention may be one or more of awireless network, a wired network or any combination of wireless networkand wired network. The networks utilized may include one or more of anInternet network, a wireless local area network (“LAN”), a cellularnetwork, a fiber optics network, a passive optical network, a cablenetwork, a satellite network (e.g., operating in Band C, Band Ku or BandKa), a Global System for Mobile Communication, a Personal CommunicationService, a Personal Area Network Wi-Fi, Fixed Wireless Data, IEEE802.11a, 802.11b, 802.15.1, 802.11n and 802.11g or any other wired orwireless network for transmitting and receiving a data signal. Thenetwork may utilize one or more protocols of one or more networkelements to which it is communicatively coupled. The network maytranslate to or from other protocols to one or more protocols of devicesconnected to the network. The invention may utilized a plurality ofinterconnected networks, such as, for example, a service providernetwork, the Internet, a broadcaster’s network, a cable televisionnetwork, a corporate network, and a home net.

Each of the interface descriptions preferably discloses use of at leastone communication protocol to establish handshaking or bi-directionalcommunications. These protocols preferably include but are not limitedto XML, HTTP, TCP/IP, Serial, UDP, FTP, Web Services, WAP, SMTP, SMPP,DTS, Stored Procedures, Import/Export, Global Positioning Triangulation,IM, SMS, MMS, GPRS and Flash. The storage of data may be networkaccessible storage and may be local, remote, or a combination thereof.The storage of data may utilize a redundant array of inexpensive disks,tape, disk, a storage area network, an internet small computer systemsinterface a common Internet File System, network attached storage, anetwork file system, or other computer accessible storage. The databasesused with the system preferably include but are not limited to MSSQL,Access, MySQL, Progress, Oracle, DB2, Open Source DBs and others.Operating system used with the system preferably include Microsoft 2010,XP, Vista, 200o Server, 2003 Server, 2008 Server, Windows Mobile, Linux,Android, Unix, I series, AS 400 and Apple OS.

The underlying protocol at a server is preferably Internet ProtocolSuite (Transfer Control Protocol/Internet Protocol (“TCP/IP”)), and thetransmission protocol to receive a file is preferably a file transferprotocol (“FTP”), Hypertext Transfer Protocol (“HTTP”), Secure HypertextTransfer Protocol (“HTTPS”) or other similar protocols. The transmissionprotocol ranges from SIP to MGCP to FTP and beyond. The protocol at theserver is preferably HTTPS.

It is further noted that the software described herein may be tangiblyembodied in one or more physical media, such as, but not limited to, acompact disc (“CD”), a digital versatile disc (“DVD”), a floppy disk, ahard drive, read only memory (“ROM”), random access memory (“RAM”), aswell as other physical media capable of storing software, orcombinations thereof.

Numerous references were made regarding servers, services, interfaces,portals, platforms, or other systems formed from computing devices. Itshould be appreciated that the use of such terms is deemed to representone or more computing devices having at least one processor configuredto execute software instructions stored on a computer readable tangible,non-transitory medium. For example, a server can include one or morecomputers operating as a web server, database server, or other type ofcomputer server in a manner to fulfill described roles,responsibilities, or functions. The genomic visualization system mayutilize various computing devices including servers, graphical userinterfaces, databases, engines, controllers, or other types of computingdevices operating individually or collectively. One skilled in thepertinent art will appreciate that the computing devices comprise aprocessor configured to execute software instructions stored on atangible, non-transitory computer readable storage medium (e.g., harddrive, solid state drive, RAM, flash, ROM, etc.). The softwareinstructions preferably configure the computing device to provide theroles, responsibilities, or other functionality as discussed below withrespect to the invention. In preferred embodiments, the servers,databases, or interfaces preferably exchange data using standardizedprotocols or algorithms, possibly based on HTTP, HTTPS, AES,public-private key exchanges, web service APIs, known financialtransaction protocols, or other electronic information exchangingmethods. Data exchanges preferably are conducted over the Internet, LAN,a packet-switched network, WAN, VPN, or other type of packet switchednetwork. One skilled in the pertinent art will appreciate that the formof a computer program product stored by one or more computer-readablestorage media having computer-readable program code, or instructions,embodied in or on the storage media. Any suitable computer readablestorage media may be utilized, including hard disks, CD-ROMs, opticalstorage devices, magnetic storage devices, flash devices and/or anycombination thereof. In addition, various signals representing data orevents as described herein may be transferred between a source and adestination in the form of electromagnetic waves traveling throughsignal-conducting media such as metal wires, optical fibers, and/orwireless transmission media--e.g. air and/or space. Data may movebetween various entities in any of the embodiments of the invention viaelectronic transmission or manual means. Electronic transmission mayutilize email, SMS or any other suitable method. Manual exchange mayutilize floppy disks, USB drives, CDs, DVDs or any other suitablemechanism.

An exemplary hardware configuration of a computing system utilized withthe invention preferably includes at least one processor or centralprocessing unit (CPU). The CPUs are preferably interconnected via asystem bus to a RAM, a ROM, input/output (I/O) adapter, user interfaceadapter, a communication adapter for connecting the system to a dataprocessing network, the Internet, an Intranet, a LAN, or the like, and adisplay adapter for connecting the bus to a display device.

Any combination of one or more computer readable medium(s) may beutilized with the invention. The computer readable medium may be acomputer readable signal medium or a computer readable storage medium. Acomputer readable storage medium may be, for example, but not limitedto, an electronic, magnetic, optical, electromagnetic, infrared, orsemiconductor system, apparatus, or device, or any suitable combinationof the foregoing. More specific examples (a non-exhaustive list) of thecomputer readable storage medium include an electrical connection havingone or more wires, a portable computer diskette, a hard disk, a RAM, aROM, an erasable programmable read-only memory, an optical fiber, aportable CD-ROM, an optical storage device, a magnetic storage device,or any suitable combination of the foregoing. A computer readablestorage medium may be any tangible medium that can contain, or store aprogram for use by or in connection with a system, apparatus, or devicerunning an instruction.

Computer program code for carrying out operations for aspects of theinvention may be written in any combination of one or more programminglanguages, including an object oriented programming language such asJava, Smalltalk, C++ or the like and conventional procedural programminglanguages, such as the “C” programming language or similar programminglanguages. The program code may run entirely on the user’s computer,partly on the user’s computer, as a stand-alone software package, partlyon the user’s computer and partly on a remote computer or entirely onthe remote computer or server. In the latter scenario, the remotecomputer may be connected to the user’s computer through any type ofnetwork, including a LAN or a WAN or the connection may be made to anexternal computer through the Internet using an Internet ServiceProvider.

Hypertext Transfer Protocol (“HTTP”) is a set of conventions forcontrolling the transfer of information via the Internet from a webserver computer to a client computer, and also from a client computer toa web server, and Hypertext Transfer Protocol Secure (“HTTPS”) is acommunications protocol for secure communication via a network from aweb server computer to a client computer, and also from a clientcomputer to a web server by at a minimum verifying the authenticity of aweb site.

Components of a server 1040 of the system 1000, includes a CPU component1401, a graphics component 1402, PCI/PCI Express 1403, memory 1404,non-removable storage 1407, removable storage 1408, Network Interface1409, including one or more connections to a fixed network, and SQLdatabase(s) 1045 a-1045 d, which includes the venue’s CRM. Included inthe memory 1404, is an operating system 1405, a SQL server 1406 or otherdatabase engine, and computer programs/software 1410. The server 140also includes at least one computer program configured to receive datauploads and store the data uploads in the SQL database. Alternatively,the SQL server can be installed in a separate server from the venueserver 1040.

Wireless Application Protocol (“WAP”) is an open, global specificationthat empowers users with mobile wireless communication devices (such asmobile phones) to easily access data and to interact with Websites overthe Internet through such mobile wireless communication device. WAPworks with most wireless communication networks such as CDPD, CDMA, GSM,PDC, PHS, TDMA, FLEX, reflex, iDEN, TETRA, DECT, DataTAC, Mobitex andGRPS. WAP can be built on most operating systems including PalmOS,WINDOWS, CE, FLEXOS, OS/9, JavaOS and others.

Web-Server is a computer able to simultaneously manage many Internetinformation-exchange processes at the same time. Normally, servercomputers are more powerful than client computers, and areadministratively and/or geographically centralized. An interactive-forminformation-collection process generally is controlled from a servercomputer, to which the sponsor of the process has access.

SSID (Service Set Identifier) is a 1 to 32 byte string that uniquelynames a wireless local area network.

Transfer Control Protocol/Internet Protocol (“TCP/IP”) is a protocol formoving files over the Internet.

Internet is the worldwide, decentralized totality of server computersand data-transmission paths which can supply information to a connectedand browser-equipped client computer, and can receive and forwardinformation entered from the client computer.

FTP or File Transfer Protocol is a protocol for moving files over theInternet from one computer to another.

BLUETOOTH technology is a standard short range radio link that operatesin the unlicensed 2.4 gigaHertz band.

BLUETOOTH LOW ENERGY (aka “BLE” or “BLUETOOTH LE”) is a communicationformat from the Bluetooth Special Interest Group which uses the 2.4gigaHertz band of BLUETOOTH technology but with a simpler modulationsystem that supports data pockets ranging from 8 to 27 octets, which aretransferred at 1 Mbps.

Application Programming Interface (API) is a collection of computersoftware code, usually a set of class definitions, that can perform aset of related complex tasks, but has a limited set of controls that maybe manipulated by other software-code entities. The set of controls isdeliberately limited for the sake of clarity and ease of use, so thatprogrammers do not have to work with the detail contained within thegiven API itself.

Wireless standards include 802.11a, 802.11b, 802.11 g, AX.25, 3G, CDPD,CDMA, GSM, GPRS, radio, microwave, laser, Bluetooth, 802.15, 802.16, andIrDA.

The mobile communication devices utilized with the present inventionpreferably include mobile phones, smartphones, tablet computers, PDAsand the like. Examples of smartphones include the IPHONE® smartphonefrom Apple, Inc., BLACKBERRY® smartphones from Research In Motion, theDROID® smartphone from Motorola Mobility Inc., GALAXY S® smartphonesfrom Samsung Electronics Co., Ltd, and many more. Examples of tabletcomputing devices include the IPAD® tablet from Apple Inc., and theGALAXY TAB® tablet from Samsung Electronics Co., Ltd.

A typical mobile communication device includes an accelerometer 1301,I/O (input/output) 1302, a microphone 1303, a speaker 1304, a GPSchipset 1305, a Bluetooth component 1306, a Wi-Fi component 1307, a3G/4G component 1308, RAM memory 1309, a main processor 1310, an OS(operating system) 311, applications/software 1312, a Flash memory 1313,SIM card 1314, LCD display 1315, a camera 1316, a power managementcircuit 1317, a battery 1318 or power source, a magnetometer 1319, and agyroscope 1320.

Patients with acute coronary syndrome are evaluated with point estimateEKG and serial enzyme testing. Recurrent episodes of chest pain andheart attack are often missed due to delays in EKG acquisition andidentification for subtle changes in the EKG. Patients at high risk fordisease especially in the era of emergency department overcrowding anddelays and triage and patient assessment raise the risk for serious pooroutcomes. The authors propose a continuous 12 lead central monitoringalgorithm using artificial intelligence to detect subtle changes in theEKG regardless of patient location. With application of a portable EKGmonitoring device, the EXG, will interface wirelessly with a centralprocessing unit capable of detecting subtle EKG changes dynamically andalert providers of these changes.

Serial assessments of ST segment and other subtle changes indicative ofacute coronary syndrome are time consuming, resource consuming, and canpotentially miss changes temporally as these point estimate EKGs areperformed.

The ability of AI to perform near continuous evaluation of multiple EKGson multiple patients simultaneously is something that would be anunconventional and non routine practice scope of any clinician. Thisnovel approach to evaluating patients with presentations concerning forpotential acute coronary syndrome will decrease frequency of EKGacquisition but improve patient outcome. This will lead to saving lives,saving time and give clinicians increased confidence in evaluating thesepatients.

Incorporation of the EXG device coupled with Bluetooth/wifi/RFIDtechnology and a central algorithmic artificial intelligence softwaresystem that receives data and that can interpret and identify changes inEKG morphology and other more subtle signs such as R to R wavevariability, ventricular vector changes, concerning for acute coronarysyndrome in addition to identifying rhythm changes. These subtle changesare often missed by even the most advanced clinicians. This AI will becapable of evaluating simultaneously multiple EKGs on multiple patientsacross the designated health care system and alert the appropriateclinician of potential changes.

Identifying patients with acute coronary syndrome especially in settingsaffected by long wait times, triage times, and delays in acquiringrepeat EKGs.

Clinicians can miss subtle changes in serial EKGs that AI can morereadily identify. Clinicians cannot monitor multiple EKGs on multiplepatients effectively and efficiently. Patients typically have timed EKGassessments every several hours and potentially will miss changes whenasymptomatic (i.e. without chest pain or other ACS presenting symptoms).

Continuous monitoring with AI will identify more patients with ACS thanthose without. Decreasing risk of missed acute coronary syndrome andmyocardial infarction.

Potential to monitor patients in non patient care setting such as thewaiting room, bathroom, home.

The EXG device preferably has Bluetooth connectivity adapter withintegrated alarm/alert system. Software and computer system integratedinto health care system, cell phone with app, home network, thatevaluates EKG data wirelessly transmitted.

EXG device apply to patient chest wall to continuously send EKG signalto central processing AI.

Bluetooth/Wifi/RFID adapter Sends data to central AI system.

AI Processor that evaluates rapid reassessments of EKG wave morphologyand rhythm changes to predict and diagnose acute coronary or significantcardiac arrythmias. Tangible software configured with instructions todetermine specific changes such as ST segment elevations of more than 1mm in contiguous leads in comparison to prior EKGs or set norms andalert multiple providers of these changes. The AI will also record thesefindings and transmit them to providers. The AI will answer the questionif there is a change in diagnosis and prognostication to warrantemergent treatment.

Prehospital EKG is obtained on patients for various medical complaintsand is used to identify patients with acute coronary syndrome and STelevation myocardial infarction.

Current model using point estimate EKG interpretation for what ispotentially a dynamic and evolving situation. Initial EKG may not bediagnostic and furthermore serial and repeat EKGs are traditionally nota viable option given the limitations inside an ambulance. The EXGsystem with incorporated bluetooth transmitter and linking to the PACERsystem enables identification of evolving myocardial infarction andsubtle changes consistent with acute coronary syndrome.

Utilizing the EXG device coupled with a bluetooth transmitter andintegrated with either a dedicated transmission device with the PACERsystem or simple smart phone with PACER application. Allows fortransmission of data to central AI processor for interpretation of EKGdata and observation with rhythm and EKG morphology change detection.Also provides real time information regarding changes in the EKGconcerning for acute coronary syndrome to the prehospital provider inthe event transmission is not possible. The device will send real timeinformation to advanced care providers enabling faster and more timelydetection of acute coronary syndrome. Central processing with physicianreview of EKG data will also allow for billing for physician services inthe prehospital arena that has not traditionally been done.

Dynamic and changing EKG morphology is not currently evaluated withcurrent systems for prehospital providers utilizing point estimate dataof only unique and individual EKG data. Current technology does notallow for continuous EKG monitoring for diagnosis of acute coronarysyndrome in the prehospital setting.

Application of the EXG device coupled with the PACER system andBLUETOOTH technology enable continuous AI evaluation for acute coronarysyndrome during the most critical time of patient evaluation.

One device with one single cable eliminates the need for multiplecumbersome wires attached to patients and limiting movement andportability.

With attached wireless connector allows for even greater patientmobility.

One applied device to replace all associated cables/interfaces forpatient complete monitoring while inpatient monitoring is necessary.

The EXG device will have incorporated into it standard transcutaneousoxygen sensors and temperature sensors as well as detect chest wall riseand respiratory rate.

By utilizing the EXG with incorporated multiple sensors one device isapplied to the patient throughout the inpatient stay eliminating theneed for multiple cables and connections.

One device does it all. Incorporates all relevant non invasivemonitoring data into one comprehensive, portable, wireless device.

EXG with pulse ox/temperature/respiratory detector. Transmits relevantdata regarding cardiac rhythm, pulse oximetry, respiratory rate andtemperature to local and central processing monitors with single cableor wifi/bluetooth adaptor.

Creation of this device will reduce the time to complete anelectrocardiogram (ECG) in the pre-hospital and emergency setting,eliminate systematic error in placement and interpretation of an ECGelectrode, maintain and place electrodes in the proper anatomiclocations across all body types, will not delay management in criticalcase, maintain proper skin contact through different physiologicresponses such as sweat, cold and heat, as well as through medicaltreatment such as CPR, be easy to train providers in application andplacement of ECG electrodes, and be adaptable to scenarios where spaceand situations limit ECG placement.

One embodiment of the present invention is an emergency cardiac andelectrocardiogram (ECG) electrode placement device. The device comprisesa body, electrodes, cables, a transcutaneous pulse oximeter positionedon the body, a temperature sensor, and an electrode connector. The bodypreferably comprises a first extension member, a second extensionmember, a third extension member, a fourth extension member and a fifthextensions member. The body preferably comprises a base layer composedof a flexible material, an adhesive layer composed of a flexiblematerial, and a backing layer attached to an adhesive surface of theadhesive layer. Each of the electrodes comprises a connection stud, acontact pad interface and a contact pad. The electrode connector ispositioned on the body. Each of the second extension member, the thirdextension member, the fourth extension member and the fifth extensionmember extends outward from the first extension member. Each cable ofthe plurality of cables is positioned between the base layer and theadhesive layer, and connected to a corresponding electrode of theplurality of electrodes and connected to the electrode connector. Thefirst extension member comprises a first electrode, a second electrode,a third electrode, a fourth electrode, a fifth electrode and a sixthelectrode of the plurality of electrodes. A seventh electrode of theplurality of electrodes is positioned at a far end of the secondextension member. An eight electrode of the plurality of electrodes ispositioned at a far end of the third extension member. A ninth electrodeof the plurality of electrodes is positioned at a far end of the fourthextension member. A tenth electrode of the plurality of electrodes ispositioned at a far end of the fifth extension member.

One embodiment of is an EXG with pulse ox/temperature/respiratorydetector. It transmits relevant data regarding cardiac rhythm, pulseoximetry, respiratory rate and temperature to local and centralprocessing monitors with single cable or wifi/bluetooth adaptor.

Dunphy et al., U.S. Pat. Application No. 15/853578, filed on Dec. 22,2017, for an Emergency Cardiac And Electrocardiogram Electrode PlacementSystem, is hereby incorporated by reference in its entirety.

U.S. Provisional Pat. Application No. 62/465752, filed on Mar. 1, 2017,is hereby incorporated by reference in its entirety.

McClung et al., U.S. Pat. Application No. 15/904411, filed on Feb. 25,2018, for an Emergency Cardiac And Electrocardiogram Electrode PlacementSystem, is hereby incorporated by reference in its entirety.

U.S. Provisional Pat. Application No. 62/530144, filed on Jul. 8, 2017,is hereby incorporated by reference in its entirety.

U.S. Provisional Pat. Application No. 62/679856, filed on Jun. 3, 2018,is hereby incorporated by reference in its entirety.

U.S. Provisional Pat. Application No. 62/679872, filed on Jun. 3, 2018,is hereby incorporated by reference in its entirety.

U.S. Provisional Pat. Application No. 62/679874, filed on Jun. 3, 2018,is hereby incorporated by reference in its entirety.

U.S. Provisional Pat. Application No. 62/679876, filed on Jun. 3, 2018,is hereby incorporated by reference in its entirety.

U.S. Provisional Pat. Application No. 62/679022, filed on Jun. 1, 2018,is hereby incorporated by reference in its entirety.

From the foregoing it is believed that those skilled in the pertinentart will recognize the meritorious advancement of this invention andwill readily understand that while the present invention has beendescribed in association with a preferred embodiment thereof, and otherembodiments illustrated in the accompanying drawings, numerous changesmodification and substitutions of equivalents may be made thereinwithout departing from the spirit and scope of this invention which isintended to be unlimited by the foregoing except as may appear in thefollowing appended claim. Therefore, the embodiments of the invention inwhich an exclusive property or privilege is claimed are defined in thefollowing appended claims.

We claim as our invention the following:
 1. An ergonomic cardiac andelectrocardiogram (ECG) electrode system, the system comprising: adevice comprising a body composed of a plurality of extension members,wherein the body comprises a main layer having a top surface an adhesivesurface, and a backing layer attached to an adhesive surface of theadhesive layer, an electrical conducting elastic material isincorporated into the top surface, a plurality of electrodes, each ofthe plurality of electrodes positioned on the adhesive surface of themain layer, and an electrode connector cable extending from the body; anEKG machine running an AI program; wherein the AI program continuouslyruns 12 lead EKGs at a rate of twenty EKGs per minute to continuouslymonitor a patient; wherein the AI processor evaluates rapidreassessments of EKG wave morphology and rhythm changes to predict anddiagnose acute coronary or cardiac arrhythmias using software configuredwith instructions to determine specific changes to ST segment elevationsof more than 1 mm in contiguous leads in comparison to prior EKGs, andto identify changes in EKG morphology including R to R wave variability.2. The system according to claim 1 wherein each electrode of theplurality of electrodes is connected to the electrode connector cablethrough the electrical conducting elastic material of the main layer. 3.The system according to claim 1 further comprising a plurality ofprinted wires and wherein each printed wire of the plurality of printedwires is printed on the top surface of the main layer, and connected toa corresponding electrode of the plurality of electrodes and theelectrode connector cable.
 4. The system according to claim 3 whereinthe printed wire is composed of a conducting ink or printed electricallyconductive material.
 5. The system according to claim 1 wherein a firstextension member of the plurality of extension members comprises atleast six electrodes of the plurality of electrodes; wherein a seventhelectrode of the plurality of electrodes is positioned at a far end of asecond extension member of the plurality of extension members; whereinan eight electrode of the plurality of electrodes is positioned at a farend of the third extension member of the plurality of extension members;wherein a ninth electrode of the plurality of electrodes is positionedat a far end of the fourth extension member of the plurality ofextension members; and wherein a tenth electrode of the plurality ofelectrodes is positioned at a far end of the fifth extension member ofthe plurality of extension members.
 6. The system according to claim 1wherein a continuous twelve lead central monitoring algorithm usingartificial intelligence to detect subtle changes in the EKG regardlessof patient location, with application of a portable EKG monitoringdevice, the EXG device interfaces wirelessly with a central processingunit capable of detecting subtle EKG changes dynamically and alertproviders of these changes.
 7. The system according to claim 1 furthercomprising at least one of a transcutaneous pulse oximeter positioned onthe body, a temperature sensor positioned on the body, and means formonitoring a patient’s respiratory rate.
 8. The system according toclaim 1 further comprising an electronic medical records (EMR) databasecomprising a plurality of EMRs; wherein the AI program continuouslymonitors a patient wearing the ECG electrode device and accesses the EMRof the patient at the EMR database.
 9. The system according to claim 8wherein the AI program is configured to receive a signal from the ECGdevice on a patient via a transmitter to the machine configured to runan AI program; wherein the AI program is configured to interpret thesignal at the machine using the AI program to monitor cardiac conditionsfor the patient; wherein the AI program is configured to compare thecardiac conditions to previous cardiac conditions to determine adifference; wherein the AI program is configured to generate a warningif a cardiac event is detected by the AI program.
 10. The systemaccording to claim 1 further comprising an alarm program.
 11. The systemaccording to claim 10 wherein the alarm program is configured togenerate a green light for a good signal, a red light for a poor signal,and a blue light for a cardiac event.
 12. The system according to claim10 wherein the alarm program is an audio alarm for a cardiac event. 13.A prehospital artificial intelligence continuous EKG reading andinterpretation placement system, the system comprising: an emergencycardiac and electrocardiogram (ECG) electrode device with a firstwireless transmitter; a PACER system or a mobile communication devicewith a PACER mobile application; wherein the ECG device withincorporated wireless transmitter and linking to the PACER systemenables identification of evolving myocardial infarction and subtlechanges consistent with acute coronary syndrome; wherein the PACERsystem or the PACER mobile application evaluates rapid reassessments ofEKG wave morphology and rhythm changes to predict and diagnose acutecoronary or significant cardiac arrhythmias using tangible softwareconfigured with instructions to determine specific changes to ST segmentelevations of more than 1 mm in contiguous leads in comparison to priorEKGs.